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FlowCAMA Digital Imaging Analyzer for Quantication and

Characterization of Visible and Sub-Visible Pharmaceutical Particles

FlowCAM Pharmaceutical Applications:

LyophilizedProteins

MAbFormulations APICarrierSuspensions

QCDiagnostics

StabilityStudies

LotReleaseTesting

The FlowCAM Series of imaging particle analyzers combine

industry-leading image quality with automated statistical pattern

recognition software to produce the most powerful sub-visible

particle analyzer available for the pharmaceutical industry.

The detection, enumeration and characterization of particles,

particularly sub-visible ones, in pharmaceutical formulation and

quality control environments is absolutely critical to product safety

in the industry. Light microscopy has long been the preferred

method for analysis, however it suffers from the manual nature of

the analysis, making it impossible to rapidly evaluate statistically

signicant populations. As a result, automated particle counting

techniques such as light obscuration and laser diffraction have

been used extensively for sampling larger populations.

These automated particle counters have severe drawbacks in

comparison to microscopy, however. First of all, they can onlycountparticles, and therefore can tell nothing about the type of

particles present. For example, they can not distinguish between

protein agglomerates and silicone droplets in a parenteral

sample. These systems also do not perform well with transparent

particles, either not detecting them at all, or mis-characterizing

their size.

In-ow imaging particle analysis overcomes the limitations of

particle counters while giving additional particle information

typically only found by using microscopy. A typical example of

using the FlowCAM to analyze a proteinaceous parenteral sample

is shown in Figure 1.

Figure 1: FlowCAM easily distiguishes between protein agglomerates and silicone droplets.

Volume-based particle analyzers

produce a distribution of particle

size only.

FlowCAM andVisualSpreadsheet software

automatically separates

and quanties silcone

droplets (top) and protein

agglomerates (bottom).

FLUID IMAGINGT E C H N O L O G I E S

Particle Analysis with Vision

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FlowCAM for Pharmaceutical Specications:

Parameter Value (Range)

Minimum Particle Size 1m (Count) 2m (Shape)Maximum Particle Size 50 (20X), 100 (10X), 300 (4X), 2,000m (2X)

Raw Image Field Size 1280x960 Pixels

Gray Scale/Color Resolution 8 Bits (monochrome), 24 Bits (Color)

Image Format UncompressedTIFF (only particle images saved to reduce data storage

requirements by a factor of 100 or better)

Basic Shape Measurements Equivalent Spherical Diameter (ESD), Area Based Diameter (ABD),

length, width, aspect ratio, area, volume

Advanced Morphology Measurements Circularity, Elongation, Compactness, Circle Fit, Perimeter, Convex

Perimeter, Edge Gradient

Gray-Scale and Color (optional) Measurements Intensity, Average Intensity, Sigma Intensity,Transparency, Average

Red, Green, Blue, R/G Ratio, R/B Ratio, G/B RatioSystem Options Cross-Polarized Illumination, Laser-Scatter Triggering, Fluorescence

Triggering,

Fluidics Precision Peristaltic Pump (standard), Micro Syringe Pump (optional)

Minimum Fluid Requirements 100l, 10 particles/ml, (Syringe pump precision of 0.001ml)

FlowCAM Benets:

DetectsTransparentParticles

MeasuresParticleSizeandShape

Industry-LeadingImageQuality

StatisticalPatternRecognition

AccurateonSamplesasSparseas10

Particles/ml 21CFRPart11Compliant

MonochromeorColorCamera(optional)

The FlowCAM is currently in use at major pharmaceutical

companies worldwide. The superior image quality found in the

FlowCAM gives it a critical advantage over competing products.

FlowCAMs VisualSpreadsheet software was the rst particle

analysis software package to use statistical pattern recognition

for automated particle characterization. In order to get the most

benet from statistical pattern recognition (or even value ltering,

for that matter), the quality of the particle measurements needs to

be as high as possible. The quality of the particle measurementsobtained from an image is directly proportionalto the quality of

the original image itself, so the FlowCAMs superior image quality

insures the highest level of accuracy available for ltering and

pattern recognition.

FlowCAM is also now available with an ultra-high-precision,

computer controlled syringe pump, enabling high accuracy sample

delivery with a precision of 0.001ml. For very sparse samples,

the instrument can be equipped with a laser-scatter triggering

option, enabling highly accurate counting down to concentrations

as low as 10 particles/ml. Finally, for applications which might

use uorescence tagging, the FlowCAM can be equipped foruorescence triggering and measurements.

Contact Fluid Imaging today to learn more about the FlowCAM,

the rst microscopic uid imaging device commercially available,

and still the industry leader!

Particle Analysis with Vision